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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Mechanical
510(k) Number K922965
Device Name TUMBLE FORMS TRISTANDER
Applicant
Tumble Forms
55 Northern Blvd., Suite 301
Great Neck,  NY  11021
Applicant Contact CAROLANN KOTULA-COOK
Correspondent
Tumble Forms
55 Northern Blvd., Suite 301
Great Neck,  NY  11021
Correspondent Contact CAROLANN KOTULA-COOK
Regulation Number890.3750
Classification Product Code
INW  
Date Received06/19/1992
Decision Date 07/13/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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